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Medtronic has cleared its slate of FDA objections to quality issues at its Northridge, Calif., diabetes headquarters, receiving a closeout notice from the agency to a warning letter issued in December 2021. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and evolves, says a former Justice Department prosecutor. Read More
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices may cause serious injury or death. Read More
The latest devicemaker to follow an important FDA pathway for technological innovation in devices is French company UroMems, which has snagged a Safer Technologies Program (STeP) designation for its UroActive Smart Continence Therapy device. Read More
Over the past week, the FDA issued a correction of a docket, an authorization and two revocations of diagnostic devices and a request for comments on rapid response surveys. In addition, the agency announced a public workshop. Read More
mRNA developer Moderna and computer giant IBM have announced an agreement under which Moderna will explore next-generation technologies, including quantum computing and artificial intelligence (AI), to accelerate mRNA research and science. Read More